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FDA 510(k)

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

K-Number: K230790 · 2023-05-19

ApplicantAbbott Laboratories
Decision Date2023-05-19
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2023-05-19 under approval number K230790. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Abbott Laboratories. The 510(k) number is K230790.

When was Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series approved by the FDA?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series received FDA 510(k) clearance on 2023-05-19, under approval number K230790.

What company makes Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is manufactured by Abbott Laboratories.

What is the FDA product code for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series?

The FDA product code for Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series is DHA.

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Related Devices (Code: DHA)

K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories K163418Diazyme DZ-Lite Total beta-hCG Test SystemDiazyme Laboratories K192790Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. K192547MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc. K203227Elecsys HCG STATRoche Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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